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FDA 510(k)

SURGVIEW INTEGRATED VISUALIZATION SYSTEM

K-Number: K082293 · 2008-09-09

ApplicantBiovision Technologies, LLC
Decision Date2008-09-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SURGVIEW INTEGRATED VISUALIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biovision Technologies, LLC. It received FDA 510(k) clearance on 2008-09-09 under 510(k) number K082293. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGVIEW INTEGRATED VISUALIZATION SYSTEM?

SURGVIEW INTEGRATED VISUALIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-09-09. The listed applicant is Biovision Technologies, LLC. The 510(k) number is K082293.

When did SURGVIEW INTEGRATED VISUALIZATION SYSTEM receive FDA 510(k) clearance?

SURGVIEW INTEGRATED VISUALIZATION SYSTEM received FDA 510(k) clearance on 2008-09-09, under 510(k) number K082293.

Who is the listed applicant for SURGVIEW INTEGRATED VISUALIZATION SYSTEM?

The FDA 510(k) record lists Biovision Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGVIEW INTEGRATED VISUALIZATION SYSTEM?

The FDA product code for SURGVIEW INTEGRATED VISUALIZATION SYSTEM is HRX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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